FDA.report

Mini and Micro Fragments Reconstruction System - GMReis

Primary DI
07899258602653
Brand
Mini and Micro Fragments Reconstruction System - GMReis
Company
GM DOS REIS INDUSTRIA E COMERCIO LTDA
Model
MINI VERSA SCREW TORXDRIVE TI T6 Ø2,3x8,0mm
Catalog number
308-23-08-C
Published
2025-12-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
HRSPlate, Fixation, Bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07899258602653PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07899258602653078992586026537899258602653

GMDN Terms

TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
900865213
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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07899258660912Orthopedic Instruments4.5 Hex Wrench353-109-10342026-02-20
07899258660929Orthopedic InstrumentsHex wrench 4.0353-109-10352026-02-20
07899258660936Orthopedic Instruments3.5 hex wrench353-109-10362026-02-20
07899258660943Orthopedic InstrumentsHex wrench 3.0353-109-10372026-02-20
07899258660950Orthopedic Instruments2.5 Hex Wrench353-109-10382026-02-20
07899258660967Orthopedic InstrumentsHex wrench 2.0353-109-10392026-02-20
07899258660974Orthopedic InstrumentsHex wrench 1.5353-109-10402026-02-20
07899258660981Orthopedic Instruments5.0 Hex wrench353-109-10332026-02-20
07899258660998Orthopedic Instruments5.5 Hex Wrench353-109-10322026-02-20
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